Erectile Dysfunction Following Radical Prostatectomy

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Review clinical trials related to Erectile Dysfunction Following Radical Prostatectomy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

EVERiST: Impact of Image Detected Accessory Pudendal Artery on Erection Recovery After Nerve Sparing Prostatectomy

Prostate cancer is the most common cancer amongst men in the United Kingdom, and two common curative treatments are surgery to remove the prostate (radical prostatectomy) or radiotherapy. Both treatments can affect quality of life, mainly because of problems with erections and urinary leakage. Many men feel disappointed or regret their treatment choice because of changes in their sexual function. Surgeons often use a 'nerve-sparing' technique to reduce the risk of erectile dysfunction (ED), but many men still experience erection problems afterwards. A way to improve erectile function recovery after surgery further would be to identify accessory (additional) arteries to the penis. Up to one in three men have an extra artery called the accessory pudendal artery (APA). Preserving this artery during surgery may improve recovery of erections by protecting blood flow and reducing the risk or severity of ED. Until recently, surgeons could only try to see these arteries during the operation, and no study has tested whether they are preserved or whether this makes a difference. This has changed with the advent of imaging. Men already have an advanced MRI scan (called a multiparametric MRI) before prostate cancer treatment. These scans can also show whether an APA is present. In addition, robotic surgery, now the gold standard for radical prostatectomy, allows operations to be video recorded. This allows comparison of what was seen on the scan with what happened during surgery and then monitoring of recovery afterwards. Early research suggests that men with an APA have better erections before surgery. This study will test whether preserving the APA during surgery helps erections recover afterwards. In this first phase of the research (Phase 1), a feasibility study will be carried out at University College London Hospital. The study will invite 20-40 men with good sexual function before surgery, who are having robotic prostatectomy with a nerve-sparing approach. Multiparametric MRI scans will be used to identify whether an APA is present and video recordings will be collected to see if the artery was preserved. Participants will complete simple questionnaires on erections and quality of life before and after surgery up to 1 year. To assess whether the artery was preserved, an extra MRI scan will be organised after surgery for those with an APA, as well as penile ultrasound to assess erectile machinery. Ethical approval has already been obtained from the regulatory bodies, and the study is ready to start recruiting participants. The results will allow planning of a larger, national study (Phase 2). That study will test whether preserving the APA improves erectile recovery, reduces the severity of ED, and improves quality of life. If confirmed, this research could lead to modification in surgical approach, more personalised counselling before surgery, and reduced long-term need for costly ED treatments within the NHS.

Participants needed: 40
Trial details
Age: 18-79Biological sex: MaleType: ObservationalSponsor: University College, LondonUpdated: May 19, 2026Locations: 1
Eligibility criteria

Men diagnosed with cT2-T3a N0 M0 PCa aged between 18 and 79 from all ethnic back... [+7]

Established moderate/ severe ED (IIEF-EFD <24) [+7]

Status: Not yet recruiting

Multimodal Prehabilitation and Rehabilitation for Men Undergoing Robot-Assisted Radical Prostatectomy

Prostate cancer is the most common cancer in Australian men. Robot-assisted radical prostatectomy (RARP) - surgical removal of the prostate - is a standard treatment, but it frequently causes erectile dysfunction (ED) and urinary incontinence that can persist for years and significantly affect quality of life. This trial (ROBOPREP) will test whether a multimodal program of prehabilitation (before surgery) and rehabilitation (after surgery) improves erectile function and urinary continence in men undergoing RARP, compared to standard care alone. The program includes four components, all delivered virtually and in a self-directed manner: 1. Pharmacological - tadalafil 5 mg once daily (a low-dose, TGA-approved erectile medication) beginning 4 weeks before surgery, paused during hospital admission, and resumed for 3 months following catheter removal after surgery. 2. Exercise - pelvic floor muscle training (3 sets per day) and aerobic exercise (40 minutes, 4 times per week) to strengthen the muscles and vascular supply involved in erectile and urinary function. 3. Nutrition - dietary guidance to support surgical recovery and vascular health. 4. Psychological/wellbeing - relaxation techniques, psychoeducation about expected recovery, and self-compassion strategies to address cancer-related anxiety. A total of 64 men will be recruited across three major Sydney hospitals (Royal Prince Alfred Hospital, Concord Repatriation General Hospital, and Chris O'Brien Lifehouse) and randomly assigned 1:1 to the multimodal program plus standard care, or to standard care alone. Outcomes - including erectile function (primary), urinary continence, quality of life, and psychological wellbeing - are assessed at baseline and at 6 weeks, 3, 6, and 12 months following surgery. All participant-facing elements of the program are digital, low-cost, and designed for real-world scalability.

Participants needed: 64
Trial details
Phase: Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Surgical Outcomes Research Centre (SOuRCe)Updated: May 8, 2026Locations: 3
Eligibility criteria

Adults aged ≥18 years undergoing elective robot-assisted radical prostatectomy (... [+2]

Cognitive impairment such that they lack capacity to provide informed consent. [+13]

Status: Recruiting

The Effect of Mobile-Based Perioperative Education on Urinary Incontinence and Erectile Function After Radical Prostatectomy

This prospective randomized controlled study aims to evaluate the effect of mobile-based perioperative education on postoperative urinary incontinence and erectile function in patients undergoing radical prostatectomy. Patients scheduled for radical prostatectomy will be assigned to either an intervention group or a control group. The intervention group will receive standard care plus a structured mobile application-based perioperative education program including video-assisted pelvic floor muscle training, perioperative education modules, reminders, and follow-up components. The control group will receive routine perioperative care and standard patient education. Data will be collected preoperatively, after urinary catheter removal, and at 1 month and 3 months after surgery. The primary outcomes are urinary incontinence and erectile function, assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), the International Index of Erectile Function-5 (IIEF-5), and a 24-hour pad assessment. Secondary outcomes include lower urinary tract symptoms and disease-specific quality of life assessed by the International Prostate Symptom Score (IPSS), psychological status assessed by the Depression Anxiety Stress Scale-21 (DASS-21), and system usability assessed by the Turkish version of the Computer System Usability Questionnaire-Short Version (T-CSUQ-SV)

Participants needed: 78
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Giresun UniversityUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Patients diagnosed with prostate cancer and scheduled for elective radical prost... [+4]

Pre-existing urinary incontinence or erectile dysfunction before surgery [+4]

Status: Recruiting

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Participants needed: 20
Trial details
Age: 30-70Biological sex: MaleType: InterventionalSponsor: Comphya AustraliaUpdated: Mar 18, 2026Locations: 4
Eligibility criteria

Men of ages between 30-70 years; [+5]

Men with neurological disease, including a history of spinal cord injury or trau... [+14]

Status: Recruiting

A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery

A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).

Participants needed: 100
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Sir Mortimer B. Davis - Jewish General HospitalUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR [+2]

Patients aged < 18 years at diagnosis [+13]

Status: Recruiting

Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain

The purpose of this study to perform a randomized, sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome.

Participants needed: 186
Trial details
Age: 40+Biological sex: MaleType: InterventionalSponsor: The Cleveland ClinicUpdated: Jan 21, 2026Locations: 1
Eligibility criteria

Cis-gendered heterosexual adult males18 years old [+5]

Nerve-injury related ED (/spinal cord injury, severe lumbosacral disorder (radic... [+22]

Status: Recruiting

Safety and Tolerability of a Novel Implantable Device for the Treatment of Erectile Dysfunction

The goal of this clinical trial is to assess if a new device is safe to use as a potential treatment for erectile dysfunction following radical prostatectomy. The main questions it aims to answer are: * Is the device safe? * Does the device works well? Are the participants satisfied with the device? Participants will be implanted with the device during the ongoing prostatectomy surgery and will be asked to complete the following tasks during 6 months follow-up: * Come to the hospital for follow-up visits, * Complete questionnaires, * Activate the device every day, * Measure erection hardness. Researchers will compare an implanted group (participants having the device) with a control group (participants not having the device) to see if the device works well.

Participants needed: 20
Trial details
Age: 30-75Biological sex: MaleType: InterventionalSponsor: Comphya Inc.Updated: Nov 10, 2025Locations: 1
Eligibility criteria

Men of ages between 30-75 years with indication for nerve-sparing prostatectomy... [+5]

Men with neurological disease, including a history of spinal cord injury or trau... [+15]

Status: Not yet recruiting

Pelvic Floor Muscle Training With Aerobic Exercise and Relaxation After Radical Prostatectomy

Post-prostatectomy urinary incontinence (PP-UI) and erectile dysfunction (ED) are common complications after radical prostatectomy, negatively affecting quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment, but recent evidence suggests that multimodal, structured rehabilitation may further improve recovery. This randomized controlled trial will investigate the additional effects of aerobic exercise and relaxation training combined with PFMT in men following nerve-sparing robotic-assisted radical prostatectomy. Forty-eight participants aged 40-65 years, within one year post-surgery, who demonstrate voluntary pelvic floor muscle contraction and sufficient cognitive function (MoCA), will be randomly assigned (1:1) to intervention or control groups. All participants will receive standardized education and a 12-week supervised PFMT program with biofeedback and home-based exercises. The intervention group will additionally perform treadmill-based aerobic exercise three times per week and structured relaxation training once per week. Primary outcomes include urinary symptoms (ICIQ-MLUTS), erectile function (IIEF-15), and prostate cancer-specific quality of life (EPIC). Secondary outcomes include pad test, ICIQ-SF, 6-minute walk test, MoCA, HADS, and adherence. This non-commercial study aims to provide high-quality evidence supporting physiotherapy-based multimodal rehabilitation for improved pelvic health and quality of life in men after prostate cancer surgery.

Participants needed: 48
Trial details
Age: 40-65Biological sex: MaleType: InterventionalSponsor: Hacettepe UniversityUpdated: Sep 15, 2025
Eligibility criteria

Male participants aged 40 to 65 years [+3]

Presence of acute illness (e.g., urinary tract infection, respiratory infection,... [+7]

Status: Recruiting

Regenerative Injection of Stem Cells or Stem Cell-derived Exosomes for Erectile Dysfunction (RISE)

The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra). The main questions the study aims to answer are: Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound? Participants will: Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis. Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment. Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.

Participants needed: 30
Trial details
Age: 30-75Biological sex: MaleType: ObservationalSponsor: Jumeirah American ClinicUpdated: Aug 26, 2025Locations: 1
Eligibility criteria

Age: Adult males aged 30 to 75 years. [+4]

Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, inc... [+7]

Status: Not yet recruiting

Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.

This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.

Participants needed: 10
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Sir Mortimer B. Davis - Jewish General HospitalUpdated: Aug 24, 2025
Eligibility criteria

Patients undergoing standard of care radical cystectomy for bladder cancer [+1]

Patients with previous pelvic surgery [+6]

Status: Recruiting

Effects of Hypopressive Exercises on Urinary Incontinence and Erectile Dysfunction After Radical Prostatectomy

This randomized controlled trial investigates the effects of hypopressive exercises on urinary incontinence and erectile dysfunction in men following radical prostatectomy. Participants will be randomly assigned to one of two groups: a control group receiving home-based pelvic floor muscle exercises and an experimental group receiving both pelvic floor muscle exercises and supervised hypopressive exercises twice per week. The study aims to determine whether the addition of hypopressive techniques, which target coordinated activation of the pelvic floor and abdominal muscles without increasing intra-abdominal pressure, offers greater improvements in urinary and sexual function. Primary outcomes include pelvic floor muscle strength and endurance, while secondary outcomes include urinary incontinence severity, erectile function, and quality of life.

Participants needed: 30
Trial details
Age: 55+Biological sex: MaleType: InterventionalSponsor: Bartın UnıversityUpdated: Aug 3, 2025Locations: 1
Eligibility criteria

Male individuals diagnosed with prostate cancer who have undergone radical prost... [+7]

History of urinary incontinence before surgery [+7]

Status: Recruiting

PEnile ReHABilitation After Nerve Sparing Robot-assisted Radical Prostatectomy for Prostate Cancer 2.0 (PEHAB-II)

The PEHAB-II study is prospective, randomized trial designed to assess the effect of two different rehabilitation strategies on the recovery of erectile function in nerve sparing prostatectomy patients. The two rehabilitation strategies consist of 1)12 months daily doses of 100 mg Sildenafil combined with vacuum device (VED) therapy for 10 minutes a day, five times a week or 2) Standard of care: monotherapy with an on-demand dosage of 100mg Sildenafil. The study will be performed in multiple centers in the Netherlands.

Participants needed: 198
Trial details
Phase: Phase 4Age: 18-70Biological sex: MaleType: InterventionalSponsor: The Netherlands Cancer InstituteUpdated: Mar 13, 2025Locations: 3
Eligibility criteria

Age > 18 years and < 70 years [+13]

Previous pelvic radiation therapy [+20]

Status: Recruiting

Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.

Participants needed: 200
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Charitable Union for the Research and Education of Peyronie's DiseaseUpdated: Feb 13, 2025Locations: 1
Eligibility criteria

Undergoing bilateral nerve-sparing prostatectomy [+2]

Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade... [+2]

Status: Recruiting

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.

Participants needed: 72
Trial details
Phase: Phase 2Age: 40-65Biological sex: MaleType: InterventionalSponsor: Biozeus Biopharmaceutical S.A.Updated: Oct 22, 2024Locations: 1
Eligibility criteria

Men between the ages of 40 and 65 years; [+6]

Prostate cancer in TNM stage classified as T3 or T4. [+22]

Status: Recruiting

Penile Vibratory Stimulation in the Prevention of Sexual Dysfunction and Urinary Incontinence After Radical Prostatectomy

To investigate if post-operative penile vibration stimulation kan be used to reduce or prevent sexual dysfunction and urinary incontinence after radical prostatectomy. This will be done in a randomized, controlled, non-blinded study. Men that undergo nerve preserving surgery for prostate cancer is allocated into an intervention group and a control group. A total of 100 men will be included for a power of 80%. The intervention group will be instructed to use the "Ferticare 2.0" vibrator for at least five minutes a day with an amplitude of 1 mm and frequency of 90 Hz (these settings were found in a pilot study) for a total of 9 months. Both groups will do the standard pelvic floor training program and both groups will be offered regular phosphodiesterase-5-inhibitor treatment. Before surgery, 3, 6 and 10 months after the patients will have to fill out four different questionnaires regarding sexual and urinary function, including IIEF-EF, EHS, "neglected side effects" and ICIQ-SF. (10 months is due to a wash-out period of 1 month after the intervention). The collected data will be analysed and the primary goal is to see if there is a significant difference in average spontaneous IIEF-EF score in the two groups 10 months after the surgery.

Participants needed: 100
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Herlev and Gentofte HospitalUpdated: Mar 12, 2024Locations: 1
Eligibility criteria

Men who are undergoing nerve-sparing radical prostatectomy [+2]

Urinary incontinent before surgery [+3]